Rofecoxib, a specific inhibitor of cyclooxygenase 2, with clinical efficacy comparable with that of diclofenac sodium: Results of a one-year, randomized, clinical trial in patients with osteoarthritis of the knee and hip

Abstract

for the ROFECOXIB PHASE III PROTOCOL 035 STUDY GROUP Objective. To compare the clinical efficacy of rofecoxib, a specific inhibitor of cyclooxygenase 2 (COX-2), with that of diclofenac in patients with osteoarthritis (OA) and to evaluate the safety and tolerability of rofecoxib.Methods. We performed a randomized, doubleblind, active comparator-controlled trial in 784 adults with OA of the knee or hip. Patients were randomized to 1 of 3 treatment groups: 12.5 mg of rofecoxib once daily, 25 mg of rofecoxib once daily, and 50 mg of diclofenac 3 times daily. Clinical efficacy and safety were evaluated over a 1-year continuous treatment period.Results. Rofecoxib at dosages of 12.5 and 25 mg demonstrated efficacy that was clinically comparable to that of diclofenac, as assessed by all 3 primary end points according to predefined comparability criteria. Results from secondary end points were consistent with those of the primary end points. There were small statistical differences favoring diclofenac for 2 of the end points. All treatments were well tolerated.Conclusion. Rofecoxib was well tolerated and provided efficacy that was clinically comparable, according to predefined statistical criteria, to that of 150 mg of diclofenac per day in this 1-year study. Specific inhibition of COX-2 provided therapeutic efficacy in OA.

A comparison of the cost-effectiveness of five strategies for the prevention of non-steroidal anti-inflammatory drug-induced gastrointestinal toxicity: a systematic review with economic modelling

“…The summary risk of bias was 'low' for three studies, [88][89][90] 'moderate' for 13 studies and 'high' for one study. 85 Randomisation sequence was often described as computer generated, and details of stratification were often provided.…”

“…Only three trials reported using a method of randomisation where allocation concealment could be assessed by the reviewers as 'adequate'. [88][89][90][91] Baseline characteristics appeared comparable in 14 studies, unclear in two studies and did not appear comparable in one study.…”

Use of NSAIDs, COX‐2 inhibitors, and acetaminophen and associated coprescriptions of gastroprotective agents in an elderly population

“…The COX-2 inhibitors rofecoxib and celecoxib, or coxibs, are part of a new group of agents that have an antiinflammatory effect similar to that of NSAIDs and have been found to be as effective as these drugs in reducing pain and inflammation (11)(12)(13)(14)(15)(16)(17)(18)(19). Clinical trials have demonstrated that coxibs have a low potential for causing upper GI injury compared with NSAIDs (11,15-17,19 -21).…”

Minimizing complications from nonsteroidal antiinflammatory drugs: Cost‐effectiveness of competing strategies in varying risk groups

“…We identified 11 trials reporting dyspeptic symptoms in patients receiving coxibs versus NSAID NS (10,(35)(36)(37)(38)(39)(40)(41)(42)(43)(44). A previous meta-analysis of these trials calculated a pooled risk reduction of 23% for coxibs versus NSAID NS (12).…”